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Sympathetic effects of early mobilization in patients with severe brain injuries

Completed
Conditions
Brain injury
Nervous System Diseases
Registration Number
ISRCTN56402432
Lead Sponsor
Hocoma AG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

1. Aged 18 years or over
2. Severe neurological injury - traumatic and non- traumatic injuries, requiring neurological, cardiovascular and respiratory functions monitoring 24/7 at the moment of the admission (for example subarachnoid hemorrhage, severe brain trauma, intra-parenchymal hemorrhage, ischemic vascular accident, brain anoxia)
3. Bed rest for at least 7 days
4. Continuous monitoring in the Intermediate Care Unit
5. Signed informed consent

Exclusion Criteria

Exclusion criteria for Group 1:
Not meeting the inclusion criteria.

Exclusion criteria for Group 2:
1. Amputation of a leg, with impossibility to pedal
2. Trauma or previous surgery of the feet, pelvis or lumbar column
3. Abdominal open wound
4. Extreme obesity (BMI> 35)
5. Ulcers
6. Height <150cm
7. Psychiatric disease or severe agitation

Exclusion criteria for Group 3:
1. Fixed contractions of the legs
2. Weight >135 kg
3. Leg length <70 cm or > 102 cm
4. Bone instability
5. Open ulcers or vascular disease of the legs
6. Cardiac contro-indications
7. Inadequate cooperation of the patient

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sympathetic activity is measured by detecting catecholamine (Epinephrine and Norepinephrine) and plasma free metanephrine (Metanephrine, Normetanephrine and Methoxytyramine) concentrations immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again.
Secondary Outcome Measures
NameTimeMethod
1. Blood pressure is measured using a sphygmomanometer upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again<br>2. Heart rate is measured using a heart rate montior upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again<br>3. Respiratory rate is measured using an optical breath rate sensor upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again<br>4. Cerebral blood flow velocity is measured using a transcranial Doppler (for patients with subarachnoid hemorrhage only) upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed and one hour after lying in bed again
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